MAUDE Adverse Event Report: PHILIPS ELECTRONICS NEDERLAND B.V. INGENIA ELITION X; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number	INGENIA ELITION X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a report that a floorplate was not installed according to specifications and had partly detached from the floor.It was glued to the building instead of bolted.
Additional Manufacturer Narrative
Philips has started an investigation.A follow up report will be send once the investigation has been completed.
Additional Manufacturer Narrative
Philips received a report that the rear floorplate of the patient support had become partly dislodged.Upon removal of the patient support and closer inspection of the floorplate it was determined that the floorplate had been glued to the building structure in contradiction to the prd(planning reference data) which states that the floorplates must be anchored/bolted to the floor.Together with the 3rd party contractor who installed the floorplate initially the floorplate was removed and reinstalled according to the prd.After this the patient support was placed back and the system is back in operation.Philips has initiated a capa to investigate the installation procedures, specifically related to the installation of the floor plating by the 3rd party contactors and to determine if proactive or corrective action is required.

• Brand Name: INGENIA ELITION X
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS ELECTRONICS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: dusty leppert ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 17029502
• Report Number: 3003768277-2023-03362
• Device Sequence Number: 20461898
• Product Code: LNH
• UDI-Device Identifier: 00884838088115
• UDI-Public: 884838088115
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: INGENIA ELITION X
• Device Catalogue Number: 781358
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown